Today's MedTech leaders shaping tomorrow's regulatory landscape
In 2020, executive leaders from medtech and digital health companies participated in interviews to share their experience and recommendations for industry priorities for regulatory and reimbursement in the new decade.
Conducted by a leading university, this IRB exempt study specifically interviewed founders, CEOs, and regulatory executive thought-leaders across medtech and digital health to examine trends, establish benchmarks, and inform future decision-making for regulatory and reimbursement.
MedTech & Digital Innovation study featured on DeviceTalks
Kwame Ulmer, study co-lead and former FDA deputy director and branch chief, sits down with Tom Salemi at DeviceTalks to share how this study aims to bring together the innovation ecosystem to be a part of breakthrough research to inform the advancement of regulatory and reimbursement.
What questions are explored?
How long does it really take innovations to get to market?
Do digital health and AI / ML have a clear path to market?
Is breakthrough designation breaking down regulatory barriers to access?
Is reimbursement the new barrier to innovation?
Is the U.S. the prioritized global regulatory path to 1st approval?
What is next on the regulatory and reimbursement horizon?
What information was examined?
MedTech and Digital Health companies shared insight on:
required to achieve one of the following FDA pathways for a medtech product:
Which global regulatory markets were examined?
European CE Mark
When will the study report be launched?
Jennifer McCaney, PhD
Co-Executive Director, UCLA Biodesign
Assistant Professor at the UCLA Anderson School of Management and Geffen School of Medicine, former Director of Medtech Innovator.
Kwame Ulmer, MBA
Lecturer, UCLA Anderson
Venture Partner at Wavemaker Three-Sixty Health former medtech executive, former Deputy Director at the FDA, and founder of Medtech Color.
Christian Johnson, MBA
Sr. Fellow, UCLA Biodesign
Co-Founder and Board Member of Seed Consulting Group, former strategist and marketer at Edwards Lifesciences and various startups.
Who is leading the research?
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Los Angeles, CA 90095
About this study
This study is strictly an independent research study led by the University of California Los Angeles. The investigators have no conflicts of interest to disclose. Individual company data will not be released to any regulatory bodies or entities. Study results will be published in aggregate for the benefit of advancing innovation in medical technology and digital health. This research has been certified as exempt from IRB review per 45 CFR 46.104 category 2 (IRB#20-001604).